Trial Outcomes & Findings for Evaluation of Systane Complete for the Treatment of Contact Lens Discomfort (NCT NCT03682809)
NCT ID: NCT03682809
Last Updated: 2020-04-06
Results Overview
Improvement in contact lens symptoms as measured with the Contact Lens Dry Eye Questionnaire-8 (CLDEQ-8) and CLDEQ-4 at 2 weeks compared to baseline. The CLDEQ-8 score range is 0 to 37 with 0 being the best score. Subjects were required to have a CLDEQ-8 of at least 12 in order to participate. The CLDEQ-4 is a subset of the CLDEQ-8, and it was also reported because it is a unidimensional measure of ocular discomfort in contact lens wearers. The CLDEQ-4 has a score range of 0 to 18 with 0 being the best score.
COMPLETED
PHASE4
46 participants
Baseline through 2 Weeks
2020-04-06
Participant Flow
Participant milestones
| Measure |
Systane Complete
Subjects randomized to this group will be asked to use Systane Complete once before and after contact lens use.
Systane Complete: Systane Complete is an artificial tear indicated for patients who have evaporative, aqueous deficient, or mixed dry eye.
|
No Treatment
Subjects randomized to this group will not receive a treatment.
|
|---|---|---|
|
Overall Study
STARTED
|
22
|
24
|
|
Overall Study
COMPLETED
|
22
|
24
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Systane Complete
n=22 Participants
Subjects randomized to this group will be asked to use Systane Complete once before and after contact lens use.
Systane Complete: Systane Complete is an artificial tear indicated for patients who have evaporative, aqueous deficient, or mixed dry eye.
|
No Treatment
n=24 Participants
Subjects randomized to this group will not receive a treatment.
|
Total
n=46 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
32.7 Years
n=22 Participants
|
28.8 Years
n=24 Participants
|
30.75 Years
n=46 Participants
|
|
Sex: Female, Male
Female
|
20 Participants
n=22 Participants
|
19 Participants
n=24 Participants
|
39 Participants
n=46 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=22 Participants
|
5 Participants
n=24 Participants
|
7 Participants
n=46 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Region of Enrollment
United States
|
22 participants
n=22 Participants
|
24 participants
n=24 Participants
|
46 participants
n=46 Participants
|
PRIMARY outcome
Timeframe: Baseline through 2 WeeksImprovement in contact lens symptoms as measured with the Contact Lens Dry Eye Questionnaire-8 (CLDEQ-8) and CLDEQ-4 at 2 weeks compared to baseline. The CLDEQ-8 score range is 0 to 37 with 0 being the best score. Subjects were required to have a CLDEQ-8 of at least 12 in order to participate. The CLDEQ-4 is a subset of the CLDEQ-8, and it was also reported because it is a unidimensional measure of ocular discomfort in contact lens wearers. The CLDEQ-4 has a score range of 0 to 18 with 0 being the best score.
Outcome measures
| Measure |
Systane Complete
n=22 Participants
Subjects randomized to this group will be asked to use Systane Complete once before and after contact lens use.
Systane Complete: Systane Complete is an artificial tear indicated for patients who have evaporative, aqueous deficient, or mixed dry eye.
|
No Treatment
n=24 Participants
Subjects randomized to this group will not receive a treatment.
|
|---|---|---|
|
Contact Lens Symptoms
Baseline cldeq-8 (worse eye)
|
20.41 Score on a Scale
Standard Deviation 5.40
|
18.92 Score on a Scale
Standard Deviation 4.92
|
|
Contact Lens Symptoms
2 week cldeq-8 (worse eye)
|
12.86 Score on a Scale
Standard Deviation 6.40
|
17.92 Score on a Scale
Standard Deviation 5.30
|
|
Contact Lens Symptoms
Baseline cldeq-4 (worse eye)
|
10.91 Score on a Scale
Standard Deviation 3.28
|
10.38 Score on a Scale
Standard Deviation 2.41
|
|
Contact Lens Symptoms
2 week cldeq-4 (worse eye)
|
7.14 Score on a Scale
Standard Deviation 3.50
|
10.13 Score on a Scale
Standard Deviation 2.83
|
SECONDARY outcome
Timeframe: Baseline through 2 WeeksImprovement in eye symptoms as measured with the Standardized Patient Evaluation of Eye Dryness (SPEED) at 2 weeks compared to baseline. The scale range is 0 to 28 with 0 being the best score.
Outcome measures
| Measure |
Systane Complete
n=22 Participants
Subjects randomized to this group will be asked to use Systane Complete once before and after contact lens use.
Systane Complete: Systane Complete is an artificial tear indicated for patients who have evaporative, aqueous deficient, or mixed dry eye.
|
No Treatment
n=24 Participants
Subjects randomized to this group will not receive a treatment.
|
|---|---|---|
|
End of Day Eye Comfort
Speed Score Baseline (worse eye)
|
10.27 score on a scale
Standard Deviation 3.60
|
9.67 score on a scale
Standard Deviation 3.93
|
|
End of Day Eye Comfort
Speed Score 2 weeks (worse eye)
|
7.55 score on a scale
Standard Deviation 4.31
|
9.29 score on a scale
Standard Deviation 4.14
|
SECONDARY outcome
Timeframe: Baseline through 2 WeeksImprovement in conjuctivial staining at two weeks compared to baseline using the Brien Holden Vision Institute (BHVI) scale, which measures five regions of the eye on a (0-4) scale (max of 20 per metric). A score 0 is the best possible score.
Outcome measures
| Measure |
Systane Complete
n=22 Participants
Subjects randomized to this group will be asked to use Systane Complete once before and after contact lens use.
Systane Complete: Systane Complete is an artificial tear indicated for patients who have evaporative, aqueous deficient, or mixed dry eye.
|
No Treatment
n=24 Participants
Subjects randomized to this group will not receive a treatment.
|
|---|---|---|
|
Corneal Staining
Corneal Staining Extent (baseline)
|
1.73 Units on a scale
Standard Deviation 2.45
|
1.63 Units on a scale
Standard Deviation 2.50
|
|
Corneal Staining
Corneal Staining Depth (baseline)
|
1.22 Units on a scale
Standard Deviation 1.54
|
0.92 Units on a scale
Standard Deviation 1.32
|
|
Corneal Staining
Corneal Staining Type (baseline)
|
1.18 Units on a scale
Standard Deviation 1.56
|
0.92 Units on a scale
Standard Deviation 1.32
|
|
Corneal Staining
Corneal Staining Extent (2 weeks)
|
1.41 Units on a scale
Standard Deviation 2.42
|
1.75 Units on a scale
Standard Deviation 1.98
|
|
Corneal Staining
Corneal Staining Depth (2 weeks)
|
0.91 Units on a scale
Standard Deviation 1.38
|
1.04 Units on a scale
Standard Deviation 1.30
|
|
Corneal Staining
Corneal Staining Type (2 weeks)
|
0.86 Units on a scale
Standard Deviation 1.36
|
0.92 Units on a scale
Standard Deviation 1.06
|
SECONDARY outcome
Timeframe: Baseline through 2 WeeksImprovement in tear volume as measured in mm of wetting with a Schirmer's strip at 5 mins at 2 weeks compared to baseline. The score ranges is 0 mm to 35 mm with 35 mm being the best score.
Outcome measures
| Measure |
Systane Complete
n=22 Participants
Subjects randomized to this group will be asked to use Systane Complete once before and after contact lens use.
Systane Complete: Systane Complete is an artificial tear indicated for patients who have evaporative, aqueous deficient, or mixed dry eye.
|
No Treatment
n=24 Participants
Subjects randomized to this group will not receive a treatment.
|
|---|---|---|
|
Schirmer's I Test Without Anesthetic
Schirmers Strip Baseline
|
15.68 mm
Standard Deviation 9.70
|
20.88 mm
Standard Deviation 10.65
|
|
Schirmer's I Test Without Anesthetic
Schirmers Strip (2 weeks)
|
15.41 mm
Standard Deviation 9.29
|
18.30 mm
Standard Deviation 10.69
|
SECONDARY outcome
Timeframe: Baseline through 2 WeeksImprovement in tear break up time as measured with a slit-lamp biomicroscope and sodium fluorescein in seconds at 2 weeks compared to baseline. Scores range for 0 to 60 seconds with 60 seconds being the best score.
Outcome measures
| Measure |
Systane Complete
n=22 Participants
Subjects randomized to this group will be asked to use Systane Complete once before and after contact lens use.
Systane Complete: Systane Complete is an artificial tear indicated for patients who have evaporative, aqueous deficient, or mixed dry eye.
|
No Treatment
n=24 Participants
Subjects randomized to this group will not receive a treatment.
|
|---|---|---|
|
Tear Break-Up Time (TBUT)
Tear Break Up Time (seconds) (baseline)
|
7.70 Seconds
Standard Deviation 5.20
|
8.50 Seconds
Standard Deviation 5.10
|
|
Tear Break-Up Time (TBUT)
Tear Break Up Time (seconds) (2 weeks)
|
8.57 Seconds
Standard Deviation 4.73
|
8.80 Seconds
Standard Deviation 5.08
|
Adverse Events
Systane Complete
No Treatment
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Dr. Andrew Pucker
The University of Alabama at Birmingham
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place